TY - JOUR
T1 - Weekly irinotecan combined with carboplatin for patients with small-cell lung cancer
T2 - A phase I study
AU - Ishimoto, Osamu
AU - Sugawara, Shunichi
AU - Inoue, Akira
AU - Maemondo, Makoto
AU - Nukiwa, Toshihiro
N1 - Funding Information:
Osamu Ishimoto, Shunichi Sugawara, and Akira Inoue declare no conflicts of interest. Makoto Maemondo received lecture fees from Chugai, Lilly, and Astra Zeneca and research funding from Boehringer Ingelheim. Toshihiro Nukiwa received manuscript fees from Boehringer Ingelheim and Shionogi Pharmaceutical Co.
Publisher Copyright:
© 2015 The Japanese Respiratory Society.
PY - 2015/7/1
Y1 - 2015/7/1
N2 - Background: We conducted a phase I dose escalation study to evaluate the feasibility, maximum tolerated dose (MTD), and recommended dose (RD) of weekly irinotecan combined with fixed-dose carboplatin for patients with untreated small-cell lung cancer (SCLC). Methods: Fifteen patients with chemotherapy-naïve SCLC less than 75 years old were enrolled from 3 institutions. Patients received irinotecan (50-80mg/m2 on days 1 and 8) and carboplatin (area under the curve, 5.0 on day 1) every 3 weeks, with 3-6 patients treated at each irinotecan dosage level (levels I-IV). The MTD was defined as the dose at which 33% of patients experienced dose-limiting toxicity. Results: Eleven patients had a performance status of 1, and 7 patients were more than 70 years old. All but 1 patient were diagnosed with extensive disease. In total, 2 of 3 patients enrolled at level IV (80mg/m2) experienced grade 3 diarrhea. Therefore, the MTD was defined as the level IV dose, and the RD was defined as the level III dose (70mg/m2). Grade 3 or 4 neutropenia was observed in 60% of patients, and febrile neutropenia was observed in 13% of patients. Four patients experienced grade 3 or 4 anemia, and 6 patients experienced grade 3 or 4 thrombocytopenia. The most common non-hematological adverse events were nausea/vomiting, diarrhea, hypokalemia, and hyponatremia. Conclusions: The MTD of weekly irinotecan was 80mg/m2, resulting in an RD of 70mg/m2 for phase II trials.
AB - Background: We conducted a phase I dose escalation study to evaluate the feasibility, maximum tolerated dose (MTD), and recommended dose (RD) of weekly irinotecan combined with fixed-dose carboplatin for patients with untreated small-cell lung cancer (SCLC). Methods: Fifteen patients with chemotherapy-naïve SCLC less than 75 years old were enrolled from 3 institutions. Patients received irinotecan (50-80mg/m2 on days 1 and 8) and carboplatin (area under the curve, 5.0 on day 1) every 3 weeks, with 3-6 patients treated at each irinotecan dosage level (levels I-IV). The MTD was defined as the dose at which 33% of patients experienced dose-limiting toxicity. Results: Eleven patients had a performance status of 1, and 7 patients were more than 70 years old. All but 1 patient were diagnosed with extensive disease. In total, 2 of 3 patients enrolled at level IV (80mg/m2) experienced grade 3 diarrhea. Therefore, the MTD was defined as the level IV dose, and the RD was defined as the level III dose (70mg/m2). Grade 3 or 4 neutropenia was observed in 60% of patients, and febrile neutropenia was observed in 13% of patients. Four patients experienced grade 3 or 4 anemia, and 6 patients experienced grade 3 or 4 thrombocytopenia. The most common non-hematological adverse events were nausea/vomiting, diarrhea, hypokalemia, and hyponatremia. Conclusions: The MTD of weekly irinotecan was 80mg/m2, resulting in an RD of 70mg/m2 for phase II trials.
KW - Carboplatin
KW - Chemotherapy
KW - Irinotecan
KW - Phase I study
KW - Small-cell lung cancer
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U2 - 10.1016/j.resinv.2015.02.006
DO - 10.1016/j.resinv.2015.02.006
M3 - Article
C2 - 26100175
AN - SCOPUS:84937191187
SN - 2212-5345
VL - 53
SP - 156
EP - 160
JO - Respiratory Investigation
JF - Respiratory Investigation
IS - 4
ER -
